1. OBJECTIVE 1.1. Change control is a quality tool and a management to maintain and keep the records of all changes as a history. Changes can be related to facility, documentation, system, equipment, instrument, procedure, layouts and products etc. 1.2. To lay down a procedure to describe the handling ...

The pharmaceutical industry is the most impactful industry for human beings because it has direct impact on people’s lives. But the pharmaceutical industry is also a business and the personnel working in pharmaceutical industry can make errors like any other industries. These human errors can lead ...

Change Control is a set of coordinated activities through which the desired change is implemented in an existing function, process, or product. Changes should be reported through change control system in Production, Quality control, Quality assurance, Stores, Engineering and R&D departments. two ...

The most important steps in successfully implementing change management in a pharma company is writing an effective change control. Some tips to help to write a proposal that will be successful: 1. Start by identifying the goal of change. This will help you determine whether the proposed change is necessary ...

To write an effective change control justification, you must first understand the purpose of the change. You also need to consider the risks associated with each change. Next, you need to create a plan to implement the change. Finally, you need to track progress and ensure that all changes are implemented ...

Objective: Change control is a formal system by which qualified representatives from appropriate disciplines including quality organization, review proposed changes that might affect validated status, regulatory compliance or in-house specifications. The representatives will define & approve appropriate ...